FDA Gives Green Light To New Fall Vaccines
On Thursday, the U.S. Food and Drug Administration (FDA) approved updated COVID-19 vaccines to better protect against the virus. This year’s approval for the updated mRNA vaccines comes earlier than in 2023, when fall vaccines were authorized on September 11. The new vaccines from Moderna and Pfizer are designed to target the KP.2 variant of the Omicron strain, according to the FDA.
These updated vaccines aim to offer enhanced protection against severe outcomes of COVID-19, such as hospitalization and death. The FDA had previously directed Moderna and Pfizer to focus on the JN.1 lineage of SARS-CoV-2 for the autumn vaccines, which has since been refined to include the KP.2 strain. Currently, the prevalent COVID-19 variant is KP.3.1.1, which accounts for 37% of recent cases and, along with KP.2, is a variant of the JN.1 lineage within the Omicron family.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized that these updated vaccines adhere to rigorous standards for safety and efficacy. He stressed the importance of vaccination as the primary means of COVID-19 prevention, especially given the declining immunity from previous exposures and vaccinations. The updated vaccines are recommended for everyone aged 6 months and older, with specific guidelines for different age groups and vaccination statuses.
For children under 5, the recommended dosage varies based on prior vaccination status, with three doses for those unvaccinated and one or two doses for those already vaccinated. Children aged 5 to 11 should receive a single dose of either vaccine, regardless of previous vaccination status, with a two-month interval from the last shot if previously vaccinated. Individuals aged 12 and older are advised to get one dose of the updated vaccine, also with a two-month gap if they were previously vaccinated. Additional doses are available for immunocompromised children aged 6 to 11.
The FDA noted that the new vaccines might cause similar side effects to those experienced with earlier mRNA vaccines. These vaccines are expected to provide protection against currently circulating variants and are produced using established manufacturing processes. The approval comes amidst a summer surge in COVID-19 cases, the highest since summer 2022, though severe cases remain lower compared to earlier pandemic years. Both Moderna and Pfizer are prepared to distribute their updated vaccines soon, while the Novavax vaccine, which uses a different production method, may take longer to become available. The CDC has recommended that all Americans over 6 months receive both the updated COVID-19 and flu vaccines this year.
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